Secura Protective Cream
FDA Label NDC 69740-311

10 label sections · Submitted to the FDA by Smith & Nephew Medical Ltd · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Smith & Nephew Medical Ltd for the product Secura Protective (NDC 69740-311). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, keep out of reach of children, directions, inactive ingredients, question or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Zinc oxide 10%

Purpose

Skin protectant

Uses

  • skin protectant
  • helps treat and prevent diaper dermatitis
  • protects minor skin irritation associated with diaper dermatitis and helps seal out wetness

Warnings

  • For external use only
  • Avoid contact with eyes
  • Not to be applied over deep or puncture wounds, infections or lacerations
  • If condition worsens or does not improve within 7 days, contact a doctor
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

Keep Out Of Reach Of Children

  • Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center immediately

Directions

  • change wet and soiled diapers, garments, and linens promptly
  • cleanse the affected area and allow to dry
  • apply cream liberally as often as necessary with each diaper, garment or linen change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged

Inactive Ingredients

water, petrolatum, cetearyl alcohol, PEG-40 castor oil, polysorbate 20, octyl palmitate, sodium cetearyl sulfate, octyl stearate, dioctyl adipate, tocopheryl acetate, methylparaben, allantoin, clove oil, propylparaben, aloe barbadensis

Question Or Comments?

1 800 876-1261

Package Label - Principal Display Panel- Tube (50G)

REF 59431100

NDC69740-311-00

Protective Cream

Skin Protectant

  • For treatment and prevention of incontinence-asssociated dermatitis
  • Pediatric tested
  • CHG compatible
  • Enriched with Allantoin, Vitamin E and Aloe
  • Clove Oil controls odor
  • Conditions and soothes

    • Smith & Nephew

    Secura ◊

    Protective Cream

    Made in India for:
    Smith & Nephew Medical Ltd, 101 Hessle Road
    Hull, HU3 2BN, England

    www.smith-nephew.com

    ◊Trademark of Smith & Nephew

    Certain markes reg’d US Pat. And Tm Off.

    59431100 (59431100)

    59431100 (59431100)

Package Label - Principal Display Panel- Tube (78G)

REF 59431200

NDC69740-312-00

Protective Cream

Skin Protectant

  • For treatment and prevention of incontinence-asssociated dermatitis
  • Pediatric tested
  • CHG compatible
  • Enriched with Allantoin, Vitamin E and Aloe
  • Clove Oil controls odor
  • Conditions and soothes

    • Smith & Nephew

    Secura ◊

    Protective Cream

    Made in India for:
    Smith & Nephew Medical Ltd, 101 Hessle Road
    Hull, HU3 2BN, England

    www.smith-nephew.com

    ◊Trademark of Smith & Nephew

    Certain markes reg’d US Pat. And Tm Off.

    59431200 (59431200)

    59431200 (59431200)

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